中国男性十一酸睾酮酯注射避孕有效性多中心研究

摘要

Objectives: To assess safety, contraceptive efficacy, reversibility, and feasibility of injectable testosterone undecanoate (TU) in tea seed oil as a hormonal male contraceptive.Methods: A total of 1,045 healthy fertile Chinese men were recruited throughout China into the study. Injections of 500 mg TU were administered monthly for 30 months. The primary outcome was pregnancy rate in the partner. Other outcomes include: semen parameters, testis volumes, reproductive hormone levels, and safety laboratory tests.Results: Forty-three participants (4. 8%) did not achieve azoospermia or severe oligozoospermia within the 6-month suppression phase. A total of 855 participants entered into the efficacy phase, and 733 participants completed monthly TU treatment and follow-up. There were nine pregnancies in 1,554/ person-year of exposure in the 24-month efficacy phase for a cumulative contraceptive failure rate of 1. 1 per 100 men. The combined method failure rate was 6. 1%, comprising 4. 8% with inadequate suppression and 1. 3% with postsuppression sperm rebound. No serious adverse events were reported. Spermatogenesis returned to the normal fertile reference range in all but two participants.Conclusion: Monthly injection of 500 mg TU provides safe, effective, reversible, and reliable contraception in a high proportion of healthy fertile Chinese men.%目的 评估十一酸睾酮酯(TU)注射避孕的安全性、有效性、可复性和可接受性. 方法 1,045名健康的有生育力的中国男性,每月一次TU 500 mg肌注共30个月,统计分析其配偶的妊娠率、精液参数、睾丸体积、生殖激素水平及安全性评估. 结果 在6个月的抑制期内有43名对象(4.8％)未达到无精子或严重少精子症；855名对象进入起效期,其中733名完成每月一次TU注射和恢复阶段.在避孕有效期的24个月,暴露1,554/人年中有9次妊娠,累计避孕失败率为1.1/100人；综合失败率6.1％,其中包括1.3％抑制不充分和4.8％短暂抑制后的精子反跳.本研究无严重不良事件报告.除了2名对象以外全部恢复生精功能,达到正常有生育力参考值范围. 结论 每月一次TU500mg肌注可以为健康有生育力的中国男性提供安全、有效、可逆的避孕.